Manager/Director Regulatory Affairs - Pleasanton, CA

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

Summary:

We are seeking an experienced Regulatory Affairs professional to lead our regulatory function. The ideal candidate will be based in the San Francisco Bay Area, have deep expertise in U.S. medical device clearance and approval processes, a strong background in reviewing marketing claims, and a solutions-oriented approach to partnering with product development, quality, marketing, clinical, and other key stakeholders. 

In This Role, You Will: 

• Develop and implement regulatory strategies to obtain FDA clearances, approvals, and compliance for new and existing medical devices. 

• Lead the preparation, submission, and maintenance of regulatory filings such as 510ks, letters to file, and responses to FDA queries. 

• Participate in the planning of long-term product development programs and short-term projects 

• Collaborate with marketing to review and approve product marketing claims, ensuring compliance with FDA regulations and guidelines. 

• Act as a strategic partner to product development teams, providing regulatory guidance and input from the product concept phase through to product launch, ensuring products are designed and developed with regulatory compliance in mind. 

• Collaborate with the medical and clinical teams to ensure clinical trial protocols align with regulatory requirements and assist in preparing regulatory submissions to support clinical trials and device approval. 

• Collaborate with product development teams to review and approve product instructions for use and product labeling, including managing GTIN/UDI. 

• Maintain current knowledge of U.S. and relevant global regulatory requirements and ensure company practices comply with applicable regulations and standards. 

• Collaborate with the quality team to ensure that the company’s Quality Management System (QMS) meets regulatory requirements and is effectively implemented. 

• Review complaint decision trees and handle regulatory reporting of events. 

• Establish and maintain domestic and international registration and product listings. 

• Participate in the risk management process, including health hazard assessments, product risk assessments, benefit-risk analysis, and reports required for the risk management file. 

• Oversee and execute medical device reporting and advisory notice activities in accordance with applicable regulations and internal procedures. 

• Participate in internal and external audits and inspections, including follow-up activities. 

• Work closely with R&D, Quality, Marketing, Clinical, Market Access, and other departments to align regulatory activities with business objectives. 

Requirements:

• Bachelor’s degree in Life Sciences, Engineering, or a related field (advanced degree preferred). 

• 7+ years of experience in regulatory affairs within the medical device industry, with a focus on U.S. FDA submissions and clearances. 

• Deep knowledge of FDA regulations and filings. 

• Expertise in reviewing and approving marketing claims in compliance with regulatory guidelines. 

• Proven track record of partnering with product development teams to provide regulatory input throughout the product lifecycle. 

• Strong analytical, problem-solving, and project management skills. 

• Excellent communication and collaboration skills, with the ability to influence cross-functional teams. 

• Knowledge of international (OUS) regulatory processes preferred 

• RAC (Regulatory Affairs Certification) preferred 

• Travel:  5% travel may be required 

• Full-time employment 

• Must be able to sit for up to 8 hours/day 

What We Offer: 

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows: 

• Competitive salary with a base range of $150,000 - $220,000 

• Stock options: ownership and a stake in growing a mission-driven company 

• Employee benefits package that includes 401(k), healthcare insurance and paid time off 

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. 
 
Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.